As mentioned before, pharmaceutical companies perform several different types of testing to ensure the safety and efficacy of their products. These tests are often referred to as analytical testing because they analyze components of the product or test for reactions with other substances.
Some of these analyzes have direct implications on how well your medicine is working and/or whether it needs to be changed or even stopped. That’s why most drug manufacturers require employees who handle drugs to undergo rigorous training and certification in order to work with medications.
Luckily, you can now find out more about what some of those tests do by reading our article! Here, we will talk about one such test that has become particularly popular over the past few years: chromatography.
What is chromatography?
Chromatography is a way to separate mixed chemicals into individual components. In general, two liquids are added together and then separated according to size.
Liquid A contains an element that will stick to (adhere to) the liquid being analyzed. This element does not remain in the mixture longer than necessary, so it can be easily removed and measured. The length of time it takes for this separation process to occur is called the column height.
Liquid B is an eluent, which are commonly used chemical reagents that cause the separated particles to dissolve and release its specific component. This information can then be determined through additional analyses.
Types of analytical tests
In pharmaceutical industry, there are several types of testing that play an integral part in ensuring the efficacy and safety of new drugs. These include chemical analysis, heath-related evaluations, and functional assessments.
All three of these test types can be done either manually or using equipment. For example, you could use spectroscopy to determine the composition of a drug, blood work to check for abnormalities, and physical examinations to assess how well your body is responding to the medication.
Each one of these has their place depending on what questions you need to ask about a particular medicine. By asking the right questions, you can ensure that the medicines you prescribe help people feel better and function at their optimal level.
Equipment for analytical testing
The term analytical test refers to any procedure that requires access to a sample of your blood or other fluids, along with use of specific equipment to determine what components are present. These tests can be done manually (done by someone else), or using automated machines.
In the pharmaceutical industry, several types of analytical testing exist. Some examples include: erythrocyte sedimentation rate (ESR) testing, complete blood count (CBC) testing, chemistries such as glucose or cholesterol levels, electrolytes like sodium or potassium, liver function tests (LFTs), genetic screening, infectious disease screenings, and drug screens to detect substances in your body that may indicate abuse or overdose.
These more advanced tests require either specialised manual tools or expensively manufactured chemicals, so they are only administered at clinical labs under close supervision. However, some less involved tests can be completed at most hospitals or doctor’s offices.
Many times, doctors will perform an initial quick check-up test before ordering the more extensive ones. Sometimes these initial tests are enough to get the necessary information you need, but if not it is okay to ask about the longer tests because there might be something similar available at another clinic.
Sample preparation for analytical testing
A fundamental part of any test is the sample collection method. Different samples require different preparatory steps to ensure the correct analysis of chemicals. For example, blood requires special treatment to determine glucose levels, while urine does not.
The type of sample collected depends on what kind of test you are doing. Some tests can be done directly with no manipulation needed, like measuring sodium levels in your serum or plasma. Others need more involved sampling methods that have dedicated terms such as liquid-liquid extraction or solid phase extraction.
These extended sample preparation techniques take extra time and cost additional materials, but they give better accuracy results.
In quality control, there are several tests that can be done to determine if a product is working properly. These include testing for acidity or pH of a liquid, checking for foam when mixing a solution with another solution, and determining whether the drug contains the correct active ingredients.
Certain products require an additional test to verify they do not contain any harmful chemicals. For example, drugs typically contain a preservative such as paraben or sodium benzoate. Because these additives could potentially interfere with the way the body processes the drug, it must be tested to make sure there are no unknown contaminants.
These tests are usually done by someone who specializes in pharmaceutical analysis, or by professionals at a laboratory. Some companies have their own internal guidelines for what needs to be tested, but most major organizations develop their own set of standards through accreditation. These certification bodies ensure that laboratories performing analyses follow well-defined procedures and use appropriate equipment and reagents.
Validation of tests
In validation, you prove that your test works for what it is intended to do. This process can be broken down into three main components: testing a hypothesis, gathering data, and analyzing results.
Validation of analytical methods typically begins with establishing a working theory or hypothesis. For example, if we wanted to determine whether an unknown substance was acidic, we could perform an experiment to see how much acid water reacts with the substance.
We would mix the two liquids together and measure the pH level of each liquid after mixing. If the pH drops, then we know our assumption about the identity of the material as being acidic is correct!
In pharmaceutical industry-related examples, this would be determining the pH level of a solution containing a known drug and measuring how much it lowers the pH of the solution. You would want to make sure there are no errors in measurement equipment or procedures, but beyond that, most people agree that drugs are usually neutral or slightly alkaline.
After the experimental setup, we must gather enough data to show conclusively that our theory is true. We cannot claim knowledge of the truth until we have done so.
This step is important because false theories may lead to wrong conclusions when doing predictive analytics like pharmacokinetic (PK) simulations or dose calculations.
In pharmaceutical industry, clinical testing is done to determine if a new drug or treatment is safe and effective for use in humans. These studies are referred to as clinical trials, and they usually have three main parts: enrollment, intervention (taking the medicine) and observation of outcomes.
During a trial’s enrollment stage, participants must agree to be part of the study by signing consent forms that give permission for their medical records to be accessed and analyzed during the experiment.
For the intervention part of the test, researchers will randomly assign individuals to either an experimental group or a control group using a randomization process. For example, patients may be given either the medication being tested or a placebo instead.
After the individual has been placed into one of these two groups, they will be monitored for a set amount of time to see how the treatments affect their health. During this period, data will be collected through various means such as questionnaires, physical exams, blood work and/or x-rays. All of this information can then be used to analyze the effects of the treatments on people’s health.
These analyses help determine whether or not the treatments were more or less effective than the controls. They also look at any possible side effects of the drugs.
Regulations and guidelines
As mentioned before, pharmaceutical companies perform many different types of tests to ensure the safety and effectiveness of their products. These are referred to as analytical testing procedures or studies- they assess whether a drug is working properly, if it has any possible side effects, and what the best formulation is for that product.
Companies also test the chemicals in the drugs to make sure they are safe. They do this by performing an extensive literature review and then conducting limited laboratory experiments with small quantities of the chemical compound.
These initial experimental trials are called preclinical research because they occur prior to human clinical trials. Companies that want to get their product approved will have to show evidence that there isn’t too much exposure to these chemicals and that they are not harmful when exposed to slightly higher levels than intended.
However, even after all of this effort, not every new experiment goes well. Sometimes things don’t work and researchers need to figure out why! When this happens, scientists must determine how to improve the substance so it works more effectively or possibly comes up with another one that does work better. This process is often called fundamental research.